About NIOX MINO ®

NIOX MINO® is the first point-of-care medical device for measuring fractional exhaled nitric oxide (FeNO), thus offering personalized asthma management. It enables healthcare providers to obtain an accurate, quantitative measure of airway inflammation to more effectively diagnose and manage asthma. Read full Intended Use statement for more information on the use of NIOX MINO® in patients with asthma.

With NIOX MINO®, clinicians may1

  • Obtain an objective measurement of airway inflammation
  • Identify patients who will be steroid responsive
  • Predict the onset of asthma symptoms and help prevent loss of asthma control
  • Assess inflammation guiding clinicians to adjust or discontinue anti-inflammatory medication as needed

Pinpoint accuracy at the point of care

NIOX MINO® brings accurate FeNO measurement to you, and enabling customized asthma management for your patients with an, easy-to-use device.

NIOX MINO® offers

  • Quality assured FeNO values
  • Individualized data management for the practice and the patient
  • The only calibration and maintenance free FeNO device

NIOX MINO® specifications

Exhaled NO – Performance Data  
Measurement range: FeNO 5 to 300 ppb
Exhalation time
10 seconds, clinical use. 6 seconds, research use
Measurement time
< 2 min
Accuracy
± 5 ppb or max 10%
Precision <3 ppb of measured value <30 ppb
<10% of measured value ≥30 ppb
Nasal NO (Research application) – Performance Data  
 Measurement range 5 to 1700 ppb
 Sampling flow rates  2 ml/s or 5 ml/s
   
Instrument memory capacity 3000 measurements
Dimensions (height x width x depth) 230 mm x 128 mm x 96 mm
Weight (including Sensor)
0.8 kg
 Shelf-life Minimum 3 years at time of delivery, or 3000 measurements.

Sensor: Maximum 12 months after opening package and mounted in NIOX MINO®.

 

Clearance and patents

NIOX MINO® is CE-marked according to In Vitro Diagnostic Device Directive 98/79/EC and approved for clinical use in EEC Countries.

NIOX MINO® is 510(k) cleared (K101034) by FDA.

Aerocrine is the holder of US Patents  5,922,610; 6,010,459; 6,038,913;  6,099,480; 6,183,416; 6,626,844; 6,723,056; 6,733,463; 6,761,185; 7,014,692; 7,270,638; 7,846,739; 5,795,787; 7,220,387; 7,533,558; 7,278,291; 7,611,671; 7,352,456; 8,181,503; 8,206,311; D448,693; D457,231; D492,035; D496,667; and patents pending.

References: 1. Dweik RA, Boggs PB, Erzurum SC, et al; on behalf of the American Thoracic Society Committee on Interpretation of Exhaled Nitric Oxide Levels (FeNO) for Clinical Applications. An official ATS clinical practice guideline: interpretation of exhaled nitric oxide levels (FeNO) for clinical applications. Am J Respir Crit Care Med. 2011;184:602-615. 2. Khalili B, Boggs PB, Bahna SL. Reliability of a new hand-held device for the measurement of exhaled nitric oxide. Allergy. 2007;62:1171-1174. 3. Data on file, Aerocrine AB.


More than 6 million tests with NIOX MINO® prove that it is the gold standard in the quantitative measurement of airway inflammation.2,3


 

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